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ACTIVE NOT RECRUITING
NCT04923893
PHASE3

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

Official title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

743

Start Date

2021-08-19

Completion Date

2036-09-22

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Bortezomib

Bortezomib will be administered SC.

DRUG

Dexamethasone

Dexamethasone will be administered orally.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Cilta-cel

Cilta-cel infusion will be administered.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUG

Fludarabine

Fludarabine will be administered intravenously.

Locations (136)

UCSF

San Francisco, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

University of Miami Health System

Miami, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University Of Maryland Medical Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New York Presbyterian-Weill Cornell Medical College

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Hospital Aleman

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Privado Universitario De Cordoba

Córdoba, Argentina

Royal Prince Alfred Hospital

Camperdown, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

Austin Health

Heidelberg, Australia

Royal Brisbane and Womens Hospital

Herston, Australia

Alfred Health

Melbourne, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Calvary Mater Newcastle Hospital

Waratah, Australia

Western Sydney Local Health District

Westmead, Australia

Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

Graz, Austria

Krankenhaus der Elisabethinen Linz

Linz, Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

Medical University of Vienna Universitatsklinik fur Innere Medizin I

Vienna, Austria

Universitair Ziekenhuis - Antwerpen

Antwerp, Belgium

AZ St.-Jan Brugge-Oostende AV

Bruges, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

Hospital Sao Rafael

Salvador, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense Universitetshospital

Odense C, Denmark

Helsinki University Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Turku University Hospital

Turku, Finland

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

Lille, France

C.H.U. Hotel Dieu - France

Nantes, France

Hopital Saint Louis

Paris, France

CHU Poitiers - Hopital la Miletrie

Poitiers, France

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, France

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, Germany

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

Tübingen, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Alexandra General Hospital of Athens

Athens, Greece

Attikon University General Hospital of Attica

Athens, Greece

G.Papanikolaou

Thessaloniki, Greece

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

St James Hospital

Dublin, Ireland

Hadassah University Hospita Ein Kerem

Jerusalem, Israel

Sheba Medical Center Tel Hashomer

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Juntendo University Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Hyogo Medical University Hospital

Hyôgo, Japan

Kanazawa University Hospital

Kanazawa, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Nagoya City University Hospital

Nagoya, Japan

Okayama University Hospital

Okayama, Japan

Hokkaido University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Japanese Red Cross Medical Center

Shibuya City, Japan

VU Medisch Centrum

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

UMC Radboud

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Oslo universitetssykehus HF, Rikshospitalet

Oslo, Norway

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

Gliwice, Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

Lisbon, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

Porto, Portugal

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Instituto Catalan Deoncologia Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. Virgen de La Arrixaca

Murcia, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Universitetssjukhuset

Linköping, Sweden

Skane University Hospital

Lund, Sweden

Universitatsspital Basel

Basel, Switzerland

Inselspital Universitatsspital Bern

Bern, Switzerland

Kantonsspital St Gallen

Sankt Gallen, Switzerland

University Hospitals Birmingham NHS Trust,

Birmingham, United Kingdom

Bristol Royal Infirmary

Bristol, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University College Hospital

London, United Kingdom

Kings College Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom

The Royal Marsden NHS Trust Sutton

Surrey, United Kingdom